BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3971414 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13772
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS OF THE ANCHOR FOUND THAT IT DID NOT PROPERLY DETACH FROM THE ASCENDA TOOL AND WAS UNABLE TO BE USED. IT WAS NOTED ONLY THE ANCHOR DEPLOYMENT TOOL (ADT) ASSEMBLING AND ANCHOR WERE RETURNED. THERE WAS A HORIZONTAL CUT FROM THE PROXIMAL END TO THE DISTAL END OF THE ANCHOR. THE CUT WENT THROUGH THE LUMEN. THE CUT TOOK A SET FROM THE DISTAL END OF THE ANCHOR. THE APPEARANCE OF THE CUT INDICATED THE ANCHOR MAY LIKELY HAVE FOLDED OVER ON THE HYPOTUBE AT THE DISTAL END. THE ANOMALY SEEN WAS LIKELY RELATED TO SILICONE BLOCKING THAT OCCURRED BETWEEN THE INTERACTION OF THE ANCHOR AND THE HYPOTUBE.

    Description of Event or Problem · 1

    IT WAS REPORTED AS THE IMPLANTING PHYSICIAN DEPLOYED THE ANCHOR FROM THE ANCHOR DEPLOYMENT TOOL ¿IT FELT AS IF THE ANCHOR FOLDED OVER ON ITSELF.¿ IT WAS ALSO REPORTED AS THE ANCHOR WAS BEING SUTURED THE IMPLANTING PHYSICIAN NOTED THE CATHETER WAS NOT SECURED BY TENSION AND WAS FREELY MOVING INSIDE THE LUMEN OF THE ANCHOR. THE ANCHOR WAS CUT OFF FROM THE CATHETER WITH THE TOOL FROM THE 8785 ACCESSORY KIT AND A NEW ANCHOR SUCCESSFULLY DEPLOYED. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. IT WAS NOTED THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT AND THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS ¿ALIVE-NO INJURY.¿ THE PUMP WAS BEING USED TO DELIVER GABLOFEN. ADDITIONAL INFORMATION RECEIVED REPORTED THE ASCENDA ANCHOR USED SEEMED TO NOT HOLD RIGHT AWAY SO THEY REMOVED IT, REPLACED IT, AND SENT IT BACK FOR ANALYSIS. IT WAS NOTED THE IMPLANTING PHYSICIAN WAS NOT AWARE THAT THERE CAN BE A FEW SECONDS BETWEEN WHEN IT¿S DEPLOYED AND WHEN IT REACHED THE MAXIMUM HOLDING POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448401 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR